China's CDE drug application status in July 2021

Monthly inventory

CDE accepted a total of 976 acceptance numbers this month

CDE accepted a total of 163 Class 1 new drugs this month

This month, CDE accepted a total of 80 acceptance numbers that were declared based on the consistency evaluation of the quality and efficacy of generic drugs

Monthly summary

According to the statistical analysis of drug crossing data, in July 2021, the Center for Drug Evaluation (CDE) undertook a total of 976 drug registration applications (calculated by acceptance number)

Compared with the previous month, a total of 96 acceptance numbers have been increased this month, of which 92 are for chemical drugs, 5 are for biological drugs, and 7 are for traditional Chinese medicines

1.

In July 2021, CDE has undertaken a total of 697 new chemical drug registration applications (calculated based on the acceptance number)

The status of domestically-made drugs Class 1 declaration

This month, CDE accepted a total of 80 acceptance numbers for Class 1 new drugs for registration of domestically produced drugs, involving 41 varieties and 42 companies

AK3280 cream

AK3280 is a small molecule drug developed by Genentech.

R&D milestones:

On June 17, 2021, Shanghai AGCO Biophysical Technology Co.

On July 1, 2020, Shanghai Aike Biophysical Biomedical Technology Co.

Carboxamide Triazole Soft Capsules

Carboxyamine triazole soft capsule is a new type of anti-tumor chemical drug jointly developed by Guangdong Yinzhu Pharmaceutical Technology Co.

R&D milestones:

On July 8, 2021, Guangdong Yinzhu Pharmaceutical Technology Co.

From 2004 to 2019, Guangdong Yinzhu Group Co.

On February 3, 2004, Guangdong Yinzhu Group Co.

PB-201 piece

PB-201 is a small molecule drug developed by Pfizer and is a GK activator

R&D milestones:

On August 27, 2019, Pego Biomedical (Suzhou) Co.

On January 14, 2019, Paige Biopharmaceuticals (Suzhou) Co.

On March 1, 2015, there was no progress in the treatment of type 2 diabetes

On January 1, 2015, Pfizer launched a phase I clinical trial in Japan for the treatment of type 2 diabetes
.
(NCT02292433) On January 1, 2013, there is no progress in the treatment of type 2 diabetes
.
(NCT01517373; NCT01475461)

On February 1, 2012, Pfizer started a Phase II clinical trial in Bulgaria and Canada for the treatment of type 2 diabetes
.
(NCT01517373)

On November 1, 2011, Pfizer launched Phase II clinical trials in Hungary, India and the Philippines for the treatment of type 2 diabetes
.
(NCT01517373; NCT01475461)

On February 1, 2010, Pfizer launched a phase I clinical trial in the United States for the treatment of type 2 diabetes
.
(NCT01933672; NCT01272804; NCT01044537; NCT02206607)

SHR0302

SHR-0302 is a small molecule drug developed by Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
It is a STAT3 inhibitor and JAK1 inhibitor
.
This medicine is a class of Chinese chemical medicine
.
At present, the highest stage of the drug's research and development is clinical phase III, which is used to treat atopic dermatitis, psoriatic arthritis, vitiligo, ankylosing spondylitis and rheumatoid arthritis
.

R&D milestones:

On July 28, 2021, Ruishi Bio-Pharmaceutical Co.
, Ltd.
launched a phase III clinical trial in Canada for the treatment of atopic dermatitis
.
(CTR20211768)

On July 5, 2021, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
will start a Phase III clinical trial in mainland China for the treatment of psoriatic arthritis
.
(CTR20211534; NCT04957550)

On April 30, 2021, Reistone Biopharma Company Ltd will start a Phase III clinical trial in Canada for the treatment of atopic dermatitis
.
(NCT04875169)

On February 3, 2021, Ruishi Bio-Pharmaceutical Co.
, Ltd.
launched a phase III clinical trial in mainland China for the treatment of vitiligo
.
(CTR20201418)

On December 30, 2020, Reistone Biopharma Company Ltd will be established in China by Reistone Biopharma Company Ltd.

A phase III clinical trial is carried out in the mainland for the treatment of atopic dermatitis
.
(NCT04717310; NCT04875169; CTR20211768; CTR20202461)

On October 21, 2020, Ruishi Bio-Pharmaceutical Co.
, Ltd.
, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
and Shanghai Hengrui Pharmaceutical Co.
, Ltd.
launched a Phase III clinical trial in mainland China for the treatment of ankylosing spondylitis
.
(CTR20201491; NCT04481139)

On July 31, 2020, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
and Shanghai Hengrui Pharmaceutical Co.
, Ltd.
launched a Phase III clinical trial in mainland China for the treatment of rheumatoid arthritis
.
(CTR20200786; NCT04333771)

On July 31, 2020, Ruishi Bio-Pharmaceutical Co.
, Ltd.
launched a Phase II clinical trial in mainland China for the treatment of alopecia areata
.
(CTR20200343)

On May 20, 2020, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
launched a phase I clinical trial in mainland China for the treatment of liver function decline
.
(NCT04293029)

Chemical drug import category 1 declaration status

This month, the CDE accepted a total of 21 registration numbers for Class 1 new drugs for imported chemical drugs, involving 11 varieties and 20 companies
.

2.
Review of biological products

In July 2021, CDE undertook a total of 164 new biological product registration applications (calculated based on the acceptance number), 63 new drugs, 27 imported, 3 imported re-registrations, and 65 supplementary applications
.

Class 1 application status of domestic biological products registration

This month, CDE accepted a total of 46 registration numbers for Class 1 new drugs for domestic biological products, involving 41 varieties and 36 companies
.

Putrizumab Injection

Akeso Biopharma (Akeso Biopharma) is a humanized monoclonal antibody developed by Taizhou Hanzhong Biopharmaceutical Co.
, Ltd.
and Hangzhou Hansi Biopharmaceutical Co.
, Ltd.
It is a PD-1 blocker
.
The drug is a class of Chinese biological drugs
.
At present, the highest research and development stage of the drug is the application for marketing, which is used to treat high microsatellite instability cancer and melanoma
.

R&D milestones:

On July 5, 2021, Lepu Biotechnology Co.
, Ltd.
submitted a marketing application to the China National Medical Products Administration NMPA for the treatment of melanoma and hypermicrosatellite instability cancers
.
(CXSS2101008)

On January 12, 2021, Taizhou Hanzhong Biomedical Co.
, Ltd.
will carry out a phase I clinical trial in mainland China for the treatment of hepatocellular carcinoma
.
(CTR20210058)

On January 07, 2021, Hangzhou Hansi Biopharmaceutical Co.
, Ltd.
, Taizhou Hanzhong Biopharmaceutical Co.
, Ltd.
and Zhongshan Kangfang Biopharmaceutical Co.
, Ltd.
will carry out a phase II clinical trial in mainland China for the treatment of hepatocellular carcinoma
.
(NCT04741165; CTR20202078)

On December 1, 2020, Wuhan Binhui Biotechnology Co.
, Ltd.
launched a Phase II clinical trial in mainland China for the treatment of melanoma
.
(NCT04616443)

On November 5, 2020, Hangzhou Hansi Biomedical Co.
, Ltd.
, Taizhou Hanzhong Biomedical Co.
, Ltd.
and Zhongshan Kangfang Biomedical Co.
, Ltd.
launched a phase II clinical trial in mainland China for the treatment of anaplastic thyroid cancer
.
(CTR20202106; NCT04574817)

On October 13, 2020, Hangzhou Hansi Bio-Pharmaceutical Co.
, Ltd.
and Zhongshan Kangfang Bio-Pharmaceutical Co.
, Ltd.
launched a Phase II clinical trial in mainland China for the treatment of bladder cancer
.
(CTR20202169)

On September 29, 2020, Hangzhou Hansi Biopharmaceutical Co.
, Ltd.
, Taizhou Hanzhong Biopharmaceutical Co.
, Ltd.
and Zhongshan Kangfang Biopharmaceutical Co.
, Ltd.
carried out a phase III clinical trial in mainland China for the treatment of esophageal cancer and gastric cancer
.
(CTR20201055)

On September 25, 2020, Taizhou Hanzhong Biopharmaceutical Co.
, Ltd.
launched a phase III clinical trial in mainland China for the treatment of non-small cell lung cancer
.
(NCT04750083)

On September 25, 2020, Hangzhou Hansi Bio-Pharmaceutical Co.
, Ltd.
and Zhongshan Kangfang Bio-Pharmaceutical Co.
, Ltd.
launched a Phase II clinical trial in mainland China for the treatment of non-small cell lung cancer
.
(CTR20202387)

On September 16, 2020, Taizhou Hanzhong Biomedicine Co.
, Ltd.
launched a Phase III clinical trial in mainland China for the treatment of gastric cancer
.
(NCT04486651; CTR20201055)

JWCAR129

Targeting BCMA chimeric antigen receptor T cells is a chimeric antigen receptor T cell therapy (CAR-T) developed by the First Affiliated Hospital of Soochow University, which is a BCMA modulator
.
At present, the highest research and development stage of the drug is the first clinical phase
.

R&D milestones:

On December 21, 2020, the First Affiliated Hospital of Soochow University will carry out the Phase I clinical trial in Mainland China
.
(NCT04677452)

TQB2450 injection

TQB-2450 is a humanized monoclonal antibody developed by Cbt, which is a PD-L1 inhibitor
.
The drug is a class of Chinese biological drugs
.
At present, the highest development stage of the drug is clinical phase III, which is used to treat head and neck cancer, cholangiocarcinoma, renal cell carcinoma, triple-negative breast tumors, non-small cell lung cancer, small cell lung cancer and head and neck squamous cell carcinoma
.

R&D milestones:

On June 15, 2021, Chia Tai Tianqing Pharmaceutical Group Co.
, Ltd.
launched a phase II clinical trial in mainland China for the treatment of nasopharyngeal carcinoma
.
(NCT04895345)

On February 4, 2021, Chia Tai Tianqing Pharmaceutical Group Co.
, Ltd.
launched a phase III clinical trial in mainland China for the treatment of cholangiocarcinoma
.
(NCT04809142)

On December 1, 2020, Nanjing Shunxin Pharmaceutical Co.
, Ltd.
of Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
launched a Phase II clinical trial in mainland China for the treatment of non-small cell lung cancer
.
(CTR20200434)

On September 29, 2020, CP Tianqing Pharmaceutical Group Co.
, Ltd.
launched a phase II clinical trial in mainland China for the treatment of endometrial cancer
.
(NCT04574284)

On September 16, 2020, CP Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co.
, Ltd.
and CP Tianqing Pharmaceutical Group Co.
, Ltd.
launched a Phase II clinical trial in mainland China for the treatment of cervical cancer
.

(CTR20201814; NCT04623333)

On August 25, 2020, CP Tianqing Pharmaceutical Group Co.
, Ltd.
launched a phase III clinical trial in mainland China for the treatment of renal cell carcinoma
.
(NCT04523272)

On July 10, 2020, Nanjing Shunxin Pharmaceutical Co.
, Ltd.
of Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
launched a phase III clinical trial in mainland China for the treatment of triple-negative breast tumors
.
(CTR20201065)

On June 1, 2020, CP Tianqing Pharmaceutical Group Co.
, Ltd.
launched a Phase III clinical trial in mainland China for the treatment of triple-negative breast tumors
.
(NCT04405505; CTR20201065)

Imported biological products registration status of category 1 declaration

This month, CDE accepted a total of 16 acceptance numbers for the registration of imported biological products for Class 1 new drugs
.
Involving 13 varieties and 21 companies
.

3.
Review of Traditional Chinese Medicines

In July 2021, CDE has undertaken a total of 113 new Chinese medicine registration applications (calculated based on the acceptance number)
.

This month, CDE accepted a total of 7 acceptance numbers for Class 1 new drugs for Chinese medicine registration, involving 7 varieties and 6 companies
.

Evaluate application status according to consistency

This month, 80 new acceptance numbers for declarations based on consistency evaluation requirements were added
.

(Source of the above data: Yaodu-China Approval/Registration Database, Global Drug Database)

Note: All the data in the article is manually sorted, or there are errors and omissions.
For the exact data, please go to Yaodu Data
.